(42 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for spinal fusion procedures to treat degenerative disc disease, which involves mitigating a medical condition, aligning with the definition of a therapeutic device.
No
The device is described as a "Cervical Stand Alone System" for "spinal fusion procedures" and "anterior column support and stability," indicating it is an implant used for treatment, not diagnosis. The text explicitly states "DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies," implying diagnosis occurs prior to the device's use.
No
The device description clearly states it is a hybrid PEEK and Titanium spacer with Titanium bone screws and a Titanium cover plate, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Cervical Stand Alone System is a physical implant (a hybrid PEEK and Titanium spacer with screws and a cover plate) designed for surgical implantation in the cervical spine.
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used to treat a condition (degenerative disc disease) by providing structural support and stability for spinal fusion. It does not perform any diagnostic function on a biological sample.
N/A
Intended Use / Indications for Use
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Product codes
OVE
Device Description
Cervical Stand Alone system is designed to provide the biomechanical strength to a traditional or minimal invasive ACDF procedure with less disruption of patient anatomy and preserve the anatomical profile. The Cervical Stand Alone system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability. Cervical Stand Alone is a hybrid PEEK (ASTM F-2026) and Titanium (Ti-6Al-4V) spacer which incorporates Titanium Bone Screws (Ti-6Al-4V) and a Titanium Cover Plate (Ti-6Al-4V). The Cervical Stand Alone spacers are designed with a zero anterior profile and are implanted using an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Mechanical testing consisting of Static and Dynamic Axial Compression Test, Static Torsion Test, Static Compression Shear Test, Subsidence Test and Expulsion Test were conducted in accordance to ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices, ASTM F2267-04 standard for Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression and in accordance with ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Method for Intervertebral Body Fusion Devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2016
Orthofix Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K161280
Trade/Device Name: Cervical Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: May 27, 2016 Received: May 31, 2016
Dear Ms. Volosen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling Parts 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
VincentJ. Devlin -S
for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161280
Device Name Cervical Stand Alone System
Indications for Use (Describe)
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Cervical Stand Alone System
510(k) Owner Information
| Name: | Orthofix Inc. |
|---|---|
| Address: | 3451 Plano Parkway |
| Lewisville, TX 75056 | |
| Telephone Number: | 214-937-2145 |
| Fax Number: | 214-937-3322 |
| Email: | nataliavolosen@orthofix.com |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia Volosen |
| Senior Regulatory Affairs Specialist | |
| Date Prepared: | May 5, 2016 |
| Name of Device | |
| Trade Name / Proprietary Name: | Cervical Stand Alone System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | OVE - Cervical intervertebral fusion device with integrated fixation |
| Regulatory Classification: | Class II - 21 CFR § 888.3080 - Intervertebral body fusion device |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K142152 - Cervical Stand Alone, SE 1/8/2015 |
| K150619 - CONSTRUX Mini PEEK Spacer, SE 9/11/2015 | |
| (reference device) | |
| Reason for 510(k) Submission: | Line extension |
Device Description
Cervical Stand Alone system is designed to provide the biomechanical strength to a traditional or minimal invasive ACDF procedure with less disruption of patient anatomy and preserve the anatomical profile. The Cervical Stand Alone system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability. Cervical Stand Alone is a hybrid PEEK (ASTM F-2026) and Titanium (Ti-6Al-4V) spacer which incorporates Titanium Bone Screws (Ti-6Al-4V) and a Titanium Cover Plate (Ti-6Al-4V). The Cervical Stand Alone spacers are designed with a zero anterior profile and are implanted using an anterior approach.
Intended Use / Indications for Use
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD
4
is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the modified Cervical Stand Alone System are similar to the predicate devices in terms of design, size, intended use, materials, and performance characteristics.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing consisting of Static and Dynamic Axial Compression Test, Static Torsion Test, Static Compression Shear Test, Subsidence Test and Expulsion Test were conducted in accordance to ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices, ASTM F2267-04 standard for Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression and in accordance with ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Method for Intervertebral Body Fusion Devices.
Basis of Substantial Equivalence
The Cervical Stand Alone System has the same intended use, indications for use, technological characteristics, materials, the same principles of operation and similar design as the currently marketed Cervical Stand Alone System (K142152).